Trial Outcomes & Findings for SGI-110 in Participants With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) (NCT NCT01261312)
NCT ID: NCT01261312
Last Updated: 2025-01-23
Results Overview
DNA LINE-1 demethylation is defined as the largest percent decrease from baseline in methylation values within a participant between Day 8 and Day 22 of the first treatment cycle. BED was assessed based on DNA LINE-1 demethylation results and defined as the smallest dose that achieves the maximum biological pharmacodynamic (PD) effect (LINE-1 demethylation) in at least 3 successive dose levels.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
414 participants
Primary outcome timeframe
Cycle 1 Day 8
Results posted on
2025-01-23
Participant Flow
Total 94 participants with Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) were enrolled in Dose escalation Phase 1, out of which 93 received treatment; Total 108 participants with relapsed and refractory (r/r) AML were enrolled, and 103 received study treatment; 107 participants with TN AML were enrolled, and 103 participants received study treatment; 105 participants with MDS were enrolled, and 102 received study treatment in Dose expansion (DE) Phase 2.
Participant milestones
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
Participants received starting dose of guadecitabine 3 milligrams per meter square (mg/m\^2), subcutaneously (SC), daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15 of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily,from Days 1-5 of a 28-day cycle in participants with diagnosis of relapsed/refractory (r/r) AML.
|
Dose Expansion: r/r AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, dailyfrom Days 1-5, SC of a 28-day cycle in participants with a diagnosis of treatment naïve (TN) AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r Myelodysplastic Syndromes (MDS).
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase (Day 0- Week 170)
STARTED
|
44
|
35
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Day 0- Week 170)
Safety Data Set
|
44
|
34
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Day 0- Week 170)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Day 0- Week 170)
NOT COMPLETED
|
44
|
35
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
STARTED
|
0
|
0
|
0
|
25
|
28
|
55
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
Safety Data Set
|
0
|
0
|
0
|
24
|
26
|
50
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
COMPLETED
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
NOT COMPLETED
|
0
|
0
|
0
|
24
|
27
|
55
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
28
|
53
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
Safety Data Set
|
0
|
0
|
0
|
0
|
0
|
0
|
24
|
27
|
52
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
3
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
25
|
26
|
50
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
27
|
27
|
28
|
23
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
Safety Data Set
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
26
|
27
|
27
|
22
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
1
|
3
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
25
|
25
|
27
|
20
|
Reasons for withdrawal
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
Participants received starting dose of guadecitabine 3 milligrams per meter square (mg/m\^2), subcutaneously (SC), daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15 of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily,from Days 1-5 of a 28-day cycle in participants with diagnosis of relapsed/refractory (r/r) AML.
|
Dose Expansion: r/r AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, dailyfrom Days 1-5, SC of a 28-day cycle in participants with a diagnosis of treatment naïve (TN) AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r Myelodysplastic Syndromes (MDS).
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase (Day 0- Week 170)
Progressive Disease
|
27
|
26
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Day 0- Week 170)
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Day 0- Week 170)
Subject Withdrew Consent
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Day 0- Week 170)
Death
|
5
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Day 0- Week 170)
Investigator Decision
|
4
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Day 0- Week 170)
Hematopoietic Cell Transplant (HCT)
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Escalation Phase (Day 0- Week 170)
Reason not Specified
|
3
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
Progressive Disease
|
0
|
0
|
0
|
14
|
16
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
Withdrew Consent
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
Death
|
0
|
0
|
0
|
4
|
3
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
Investigator Decision
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
HCT
|
0
|
0
|
0
|
5
|
3
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r AML (Week 75-242)
Reason not Specified
|
0
|
0
|
0
|
1
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
11
|
17
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
3
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
7
|
11
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
Investigator Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
9
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
Bone marrow (BM)/Stem cell transplant
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
|
DE Phase: TN AML (Week 85-283)
Reason not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
1
|
6
|
0
|
0
|
0
|
0
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
7
|
9
|
2
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
3
|
3
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
5
|
3
|
3
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
1
|
2
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
Investigator Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
6
|
3
|
5
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
BM/Stem Cell Transplant
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
6
|
4
|
|
DE Phase: r/r MDS &TN MDS (Week 78-298)
Reason not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
1
|
Baseline Characteristics
SGI-110 in Participants With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=44 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=34 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily,from Days 1-5 of a 28-day cycle in participants with diagnosis of r/r AML.
|
Dose Expansion: r/r AML Guadecitabine 90 mg/m^2 (5-Day)
n=26 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (10-Day)
n=53 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=52 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
n=26 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
n=22 Participants
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.22 years
n=5 Participants
|
64.90 years
n=7 Participants
|
71.04 years
n=5 Participants
|
55.83 years
n=4 Participants
|
62.01 years
n=21 Participants
|
58.86 years
n=8 Participants
|
77.83 years
n=8 Participants
|
78.46 years
n=24 Participants
|
77.78 years
n=42 Participants
|
71.61 years
n=42 Participants
|
72.05 years
n=42 Participants
|
68.38 years
n=42 Participants
|
71.27 years
n=36 Participants
|
68.94 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
145 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
34 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
256 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
29 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
51 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
21 Participants
n=36 Participants
|
372 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
18 Participants
n=36 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
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
50 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
22 Participants
n=36 Participants
|
361 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 8Population: Pharmacodynamic (PD) analysis set included all participants who provided evaluable blood samples for analysis of at least one PD parameter or biomarker being tested. Overall number analyzed is number of participants with data available for analysis.
DNA LINE-1 demethylation is defined as the largest percent decrease from baseline in methylation values within a participant between Day 8 and Day 22 of the first treatment cycle. BED was assessed based on DNA LINE-1 demethylation results and defined as the smallest dose that achieves the maximum biological pharmacodynamic (PD) effect (LINE-1 demethylation) in at least 3 successive dose levels.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=30 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=28 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=11 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase- Biological Effective Dose (BED): Percent Change From Baseline in DNA Long Interspersed Nucleotide Element-1 (LINE-1) Demethylation
|
-16.143 percent change
Standard Deviation 12.692
|
-4.362 percent change
Standard Deviation 5.484
|
-10.574 percent change
Standard Deviation 8.444
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 15Population: Pharmacodynamic (PD) analysis set included all participants who provided evaluable blood samples for analysis of at least one PD parameter or biomarker being tested. Overall number analyzed is number of participants with data available for analysis.
DNA LINE-1 demethylation is defined as the largest percent decrease from baseline in methylation values within a participant between Day 8 and Day 22 of the first treatment cycle. BED was assessed based on DNA LINE-1 demethylation results and defined as the smallest dose that achieves the maximum biological pharmacodynamic (PD) effect (LINE-1 demethylation) in at least 3 successive dose levels.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=26 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=29 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=12 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase- Biological Effective Dose (BED): Percent Change From Baseline in DNA Long Interspersed Nucleotide Element-1 (LINE-1) Demethylation
|
-10.359 percent change
Standard Deviation 9.837
|
-5.312 percent change
Standard Deviation 5.796
|
-17.540 percent change
Standard Deviation 9.207
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 22Population: Pharmacodynamic (PD) analysis set included all participants who provided evaluable blood samples for analysis of at least one PD parameter or biomarker being tested. Overall number analyzed is number of participants with data available for analysis.
DNA LINE-1 demethylation is defined as the largest percent decrease from baseline in methylation values within a participant between Day 8 and Day 22 of the first treatment cycle. BED was assessed based on DNA LINE-1 demethylation results and defined as the smallest dose that achieves the maximum biological pharmacodynamic (PD) effect (LINE-1 demethylation) in at least 3 successive dose levels.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=30 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=22 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=8 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase- Biological Effective Dose (BED): Percent Change From Baseline in DNA Long Interspersed Nucleotide Element-1 (LINE-1) Demethylation
|
-6.325 percent change
Standard Deviation 7.477
|
-4.777 percent change
Standard Deviation 4.765
|
-16.959 percent change
Standard Deviation 10.112
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 2 Day 1Population: Pharmacodynamic (PD) analysis set included all participants who provided evaluable blood samples for analysis of at least one PD parameter or biomarker being tested. Overall number analyzed is number of participants with data available for analysis.
DNA LINE-1 demethylation is defined as the largest percent decrease from baseline in methylation values within a participant between Day 8 and Day 22 of the first treatment cycle. BED was assessed based on DNA LINE-1 demethylation results and defined as the smallest dose that achieves the maximum biological pharmacodynamic (PD) effect (LINE-1 demethylation) in at least 3 successive dose levels.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=24 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=19 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=5 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase- Biological Effective Dose (BED): Percent Change From Baseline in DNA Long Interspersed Nucleotide Element-1 (LINE-1) Demethylation
|
-2.805 percent change
Standard Deviation 4.249
|
-1.860 percent change
Standard Deviation 3.844
|
-13.346 percent change
Standard Deviation 6.039
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the start of study treatment up to 30 days post treatment (Up to approximately 46 months)Population: Safety data analysis set included all regimen 1, 2A and 2 B participants who received at least one dose of study drug.
The MTD was defined as the largest dose for which less than 33% of subjects experienced a dose limiting toxicity (DLT) during Cycle 1 of guadecitabine administration at each dose level. DLTs were defined using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=44 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=34 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase-Maximum Tolerated Dose (MTD): Number of Participants With Dose Limiting Toxicity (DLT)
DLT
|
2 Participants
|
0 Participants
|
0 Participants
|
—
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—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
|
Dose Escalation Phase-Maximum Tolerated Dose (MTD): Number of Participants With Dose Limiting Toxicity (DLT)
Adverse Event (AE)
|
44 Participants
|
34 Participants
|
15 Participants
|
—
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—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 38 months)Population: Efficacy analysis set included r/r AML and TN AML participants who received at least one dose of study drug.
Composite complete response (CRc) rate is defined as the percentage of participants whose best response is complete remission \[CR\], CR with incomplete platelet recovery \[CRp\], or CR with incomplete hematological recovery \[CRi\]) after treatment with study drug. CR as per AML response criteria is defined as peripheral blood absolute neutrophil count (ANC) ≥1.0×10\^9/L, Platelets ≥100×10\^9/L, independence from red blood cell (RBC) and platelet transfusions over the past week, no myeloblasts and \<5% myeloblasts in bone marrow. CRp as per AML response criteria is defined as peripheral blood ANC ≥1.0×10\^9/L, Platelets \<100×10\^9/L, independence from RBC transfusions over the past week, no myeloblasts and \<5% myeloblasts in bone marrow. CRi as per AML response criteria is defined as peripheral blood ANC \<1.0×10\^9/L, no myeloblasts and \<5% myeloblasts in bone marrow.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=24 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=26 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=53 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=52 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion (DE) Phase- r/r AML, TN AML: Composite Complete Response (CRc) Rate
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
19.2 percentage of participants
Interval 6.6 to 39.4
|
30.2 percentage of participants
Interval 18.3 to 44.3
|
54.2 percentage of participants
Interval 32.8 to 74.4
|
59.3 percentage of participants
Interval 38.8 to 77.6
|
50.0 percentage of participants
Interval 35.8 to 64.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 45 months)Population: Efficacy analysis set included r/r MDS and TN MDS participants who received at least one dose of study drug.
ORR is defined as percentage of participants with complete response(CR), partial response(PR), marrow complete response(mCR) and haematological improvement(HI). CR:normal peripheral counts with persistent granulocyte count ≥1.0×10\^9/L, platelet count ≥100×10\^9/L and normal bone marrow (BM) with persistent marrow blasts ≤5%; persistent dysplasia was noted. PR:normal peripheral counts with granulocyte count ≥1.0×10\^9/L and platelet count ≥100 ×10\^9/L and normal BM with marrow blasts \>5% but were reduced by 50% or more. mCR:reduction of BM blasts to ≤5% without normalization of peripheral counts. HI is divided as erythroid response(HI-E): hemoglobin increase ≥1.5 g/dL or red blood cells transfusion independence, platelet response (HI-P): absolute increase of platelet count from \<20 to \>20×10\^9/L and by at least 100%,/if more than 20×10\^9/L, by an absolute increase of 30×10\^9/L, neutrophil response (HI-N): granulocyte increase ≥100%, and by an absolute increase ≥0.5×10\^9/L.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=26 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=27 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=27 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=22 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion (DE) Phase- r/r MDS, TN MDS: Overall Response Rate (ORR)
|
31 percentage of participants
Interval 14.3 to 51.8
|
56 percentage of participants
Interval 35.3 to 74.5
|
48 percentage of participants
Interval 28.7 to 68.1
|
55 percentage of participants
Interval 32.2 to 75.6
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 23 months)Population: Efficacy analysis set included regimen 1, 2A and 2B participants who received at least one dose of study drug. Overall number of participants analyzed are the number of participants with AML available for analysis.
Response rate for AML participants was assessed by Modified International Working Group (IWG) 2003 response criteria with complete response (CR), complete response with incomplete platelet recovery (CRp), CR with incomplete blood count recovery(CRi), and partial response (PR). CR: absolute neutrophil count (ANC) \>1.0×10\^9/L, platelets ≥100×10\^9/L, independence from RBC and platelet transfusions, no or \<5% myeloblasts in bone marrow(BM). CRp: ANC \>1.0×10\^9/L, Platelets \<100×10\^9/L, independence from RBC transfusions, no or \<5% myeloblasts in BM. CRi: ANC \<1.0×10\^9/L, no or \<5% myeloblasts in BM. PR: ANC \>1.0×10\^9/L, Platelets ≥100×10\^9/L, no or decrease of ≥50% in myeloblasts to 5-25% in BM.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=35 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=28 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=11 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase: Response Rate in AML Participants
|
11.4 percentage of participants
Interval 3.2 to 26.7
|
7.1 percentage of participants
Interval 0.9 to 23.5
|
0.0 percentage of participants
Interval 0.0 to 28.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 23 months)Population: Efficacy analysis set included regimen 1, 2A and 2B participants who received at least one dose of study drug. Overall number of participants analyzed are the number of participants with MDS available for analysis.
Response rate for MDS participants was assessed by IWG 2006 Response Criteria with CR, PR, marrow complete response(mCR) and HI. CR: normal peripheral counts with persistent granulocyte count ≥1.0×10\^9/L, platelet count ≥100×10\^9/L; normal BM with persistent marrow blasts ≤5%; persistent dysplasia. PR: Normal peripheral counts with granulocyte count ≥1.0×10\^9/L, platelet count ≥100×10\^9/L and normal BM with blasts \>5% but reduced by 50% or more. mCR: reduction of BM blasts to ≤5% without normalization of peripheral counts.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=9 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=6 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=4 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase: Response Rate in MDS Participants
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 38 months)Population: Efficacy analysis set included regimen 1, 2A and 2B, r/r AML and TN AML participants who received at least one dose of study drug. Data for responders was reported for this outcome measure.
Duration of response (in number of days) was calculated from the first time a complete response (CR, CRp, or CRi) was observed to time of relapse defined as the earliest time point whereby BM blasts or peripheral blood blasts become ≥5% and stayed at that level in subsequent visits while participants were still on study. CR:normal peripheral counts with persistent granulocyte count ≥1.0×10\^9/L, platelet count ≥100×10\^9/L and normal bone marrow (BM) with persistent marrow blasts ≤5%; persistent dysplasia was noted. CRp as per AML response criteria is defined as peripheral blood ANC ≥1.0×10\^9/L, Platelets \<100×10\^9/L, independence from RBC transfusions over the past week, no myeloblasts and \<5% myeloblasts in bone marrow. CRi as per AML response criteria is defined as peripheral blood ANC \<1.0×10\^9/L, no myeloblasts and \<5% myeloblasts in bone marrow.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=4 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=2 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=3 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=5 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=16 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=13 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=16 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=26 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Dose Expansion Phase- r/r AML, TN AML: Duration of Response
|
213.0 days
Interval 47.0 to 350.0
|
300.0 days
Interval 42.0 to 558.0
|
—
|
816.0 days
Interval 15.0 to 880.0
|
112.0 days
Interval 55.0 to 879.0
|
233.0 days
Interval 42.0 to 898.0
|
237.0 days
Interval 8.0 to 1068.0
|
185.5 days
Interval 16.0 to 948.0
|
269.5 days
Interval 40.0 to 669.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 45 months)Population: Efficacy analysis set included regimen 1, 2A and 2B participants who received at least one dose of study drug. Overall number of participants analyzed are the number of participants with data available for analysis.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=9 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=6 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=4 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation Phase: Hematologic Improvement Rate in MDS
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 45 months)Population: Efficacy analysis set included participants with MDS who received at least one dose of study drug. Overall number of participants analyzed are the number of participants with response. Number analyzed are the number of participants with data available for analysis.
DOR was calculated from first time a response category (CR, PR, mCR, or HI) was achieved until response category was no longer met or the last available time point, whichever occurred first. CR:normal peripheral counts with persistent granulocyte count ≥1.0×10\^9/L, platelet count ≥100×10\^9/L and normal bone marrow (BM) with persistent marrow blasts ≤5%; persistent dysplasia was noted. PR:normal peripheral counts with granulocyte count ≥1.0×10\^9/L and platelet count ≥100 ×10\^9/L and normal BM with marrow blasts \>5% but were reduced by 50% or more. mCR:reduction of BM blasts to ≤5% without normalization of peripheral counts. HI is divided as erythroid response(HI-E): hemoglobin increase ≥1.5 g/dL or RBC transfusion independence, platelet response (HI-P): absolute increase of platelet count from \<20 to \>20×10\^9/L by at least 100%,/if more than 20×10\^9/L, by absolute increase of 30×10\^9/L, neutrophil response (HI-N): granulocyte increase ≥100%, by an absolute increase ≥0.5×10\^9/L.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=6 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=12 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=12 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=11 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DE Phase- r/r MDS, TN MDS: Duration of Response
CR+PR+mCR
|
295.0 days
Interval 101.0 to 529.0
|
207.0 days
Interval 42.0 to 984.0
|
103.0 days
Interval 35.0 to 1144.0
|
165.0 days
Interval 42.0 to 958.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
DE Phase- r/r MDS, TN MDS: Duration of Response
HI
|
202.5 days
Interval 91.0 to 574.0
|
193.0 days
Interval 71.0 to 1050.0
|
227.0 days
Interval 89.0 to 525.0
|
127.0 days
Interval 81.0 to 1087.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 38 months)Population: Efficacy analysis set included regimen 1, 2A and 2B, r/r AML and TN AML participants who received at least one dose of study drug. Data is reported for responders in this outcome measure.
Time to response was defined as the number of days from the day a participants received the first dose of guadecitabine (cycle 1 day 1 {C1D1}) to the first day of response. Composite complete response rate (CRc = CR + CRp + CRi), which is an overall complete response assessment including CR, CR with incomplete platelet recovery (CRp) and CR with incomplete blood count recovery (CRi). CRc rate, was defined as the number of participants who achieved a response status of CR, CRp, or CRi divided by the total number of participants included in the efficacy dataset. The CR rate is defined as the number of participants whose best response is CR divided by the total number of participants included in the efficacy dataset.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=3 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=2 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation r/r AML, TN AML: Time to Response
|
106.0 days
Interval 106.0 to 147.0
|
55.5 days
Interval 27.0 to 84.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 45 months)Population: Efficacy analysis set included r/r MDS and TN MDS participants who received at least one dose of study drug. Overall number of participants analysed are the participants with response. Number analyzed is number of participants with response.
Time to response was defined as the number of days from the day a participants received the first dose of guadecitabine (C1D1) to the first day of response. CR:normal peripheral counts with persistent granulocyte count ≥1.0×10\^9/L, platelet count ≥100×10\^9/L and normal bone marrow (BM) with persistent marrow blasts ≤5%; persistent dysplasia was noted. PR:normal peripheral counts with granulocyte count ≥1.0×10\^9/L and platelet count ≥100 ×10\^9/L and normal BM with marrow blasts \>5% but were reduced by 50% or more. mCR:reduction of BM blasts to ≤5% without normalization of peripheral counts. HI is divided as erythroid response(HI-E): hemoglobin increase ≥1.5 g/dL or RBC transfusion independence, platelet response (HI-P): absolute increase of platelet count from \<20 to \>20×10\^9/L by at least 100%,/if more than 20×10\^9/L, by absolute increase of 30×10\^9/L, neutrophil response (HI-N): granulocyte increase ≥100%, by an absolute increase ≥0.5×10\^9/L.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=6 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=12 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=12 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=11 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Expansion Phase- r/r MDS, TN MDS: Time to Response
CR+PR+mCR
|
27.0 days
Interval 25.0 to 512.0
|
68.0 days
Interval 23.0 to 189.0
|
196.0 days
Interval 24.0 to 245.0
|
133 days
Interval 47.0 to 392.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Expansion Phase- r/r MDS, TN MDS: Time to Response
HI
|
108.0 days
Interval 5.0 to 173.0
|
58.0 days
Interval 27.0 to 277.0
|
64.5 days
Interval 0.0 to 364.0
|
49.0 days
Interval 27.0 to 119.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (each cycle = 28 days)Population: Safety analysis set included data from regimen 1, 2A and 2B participants who received at least one dose of study drug.
DLT was defined using CTCAE v4.0. Toxicities were considered related to SGI-110 if it cannot be explained by underlying disease, intercurrent illness or concomitant medications. Any related Grade 3 or 4 non-hematologic toxicity except Grade 3 or 4 nausea/vomiting that is controllable by anti-emetics or diarrhea controllable by optimal therapy. Grade 3 laboratory investigations other than serum creatinine, bilirubin, AST or ALT were not considered a DLT unless they are associated with clinical manifestations. Study-drug related Grade 4 thrombocytopenia and Febrile neutropenia that was not present at study entry, and not resolve within 7 days, and is not related to underlying disease. Prolonged myelosuppression or pancytopenia with hypocellular bone marrow and no marrow blasts lasting for 6 weeks or more that is not related to disease progression. Any toxicity that results in treatment delays of \> 4 weeks. Data is reported for any AE occurring during Cycle 1 (each cycle = 28 days).
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=44 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=34 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT) Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up 30 days post treatment (up to approximately 46 months)Population: Safety data set included all participants who received at least one dose of study drug.
Treatment-emergent AEs are defined as events that first occurred or worsened after the first dose of study drug given on C1D1 until 30 days after the last dose of study treatment or the start of an alternative anti-cancer treatment for MDS/CMML and subsequent AML, whichever occurs first, with the following exceptions: events that occurred after 30 days beyond the last dose of study treatment or the start of an alternative anti-cancer treatment for MDS/CMML and subsequent AML was considered treatment-emergent if the events are both serious and related to the study treatment.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=44 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=34 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=26 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=53 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=52 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
n=26 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
n=22 Participants
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and Dose Expansion Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With At Least One Treatment-Emergent Adverse Events (TEAEs)
|
44 Participants
|
34 Participants
|
15 Participants
|
24 Participants
|
26 Participants
|
53 Participants
|
24 Participants
|
27 Participants
|
52 Participants
|
26 Participants
|
27 Participants
|
27 Participants
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up 30 days post treatment (up to approximately 46 months)Population: Safety data set included all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=44 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=34 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=26 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=53 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=52 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
n=26 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
n=22 Participants
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Alanine Aminotransferase Increased
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Hypoalbuminaemia
|
6 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Blood Alkaline Phosphatase Increased
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Blood Alkaline Phosphatase Decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Aspartate Aminotransferase Increased
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Blood Creatinine Increased
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Blood Creatinine Decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Blood Magnesium Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Blood Potassium Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Blood Bilirubin Increased
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Number of Participants With Abnormal Laboratory Values Reported as Adverse Events
Hyperbilirubinaemia
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 1, 5 and 8Population: Pharmacokinetic (PK) analysis set included all available plasma concentrations and PK parameters for guadecitabine and decitabine for participants who received study drug. Number analyzed are the number of participants with data available for analysis at the given timepoint.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=4 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=4 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=5 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=7 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=12 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=3 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
n=4 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
n=7 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
n=7 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Maximum Observed Plasma Concentration (Cmax ) of SGI-110 and Decitabine
SGI-110: Day 1
|
6.69 ng/mL
Geometric Coefficient of Variation 72.9
|
19.1 ng/mL
Geometric Coefficient of Variation 43.5
|
45.7 ng/mL
Geometric Coefficient of Variation 57.9
|
106 ng/mL
Geometric Coefficient of Variation 129
|
121 ng/mL
Geometric Coefficient of Variation 31.9
|
155 ng/mL
Geometric Coefficient of Variation 34.6
|
178 ng/mL
Geometric Coefficient of Variation 46.2
|
11.7 ng/mL
Geometric Coefficient of Variation 65.7
|
37.4 ng/mL
Geometric Coefficient of Variation 73.4
|
61.9 ng/mL
Geometric Coefficient of Variation 44.5
|
101 ng/mL
Geometric Coefficient of Variation 51.0
|
100 ng/mL
Geometric Coefficient of Variation 30.2
|
219 ng/mL
Geometric Coefficient of Variation 36.5
|
106 ng/mL
Geometric Coefficient of Variation 29.9
|
|
Dose Escalation: Maximum Observed Plasma Concentration (Cmax ) of SGI-110 and Decitabine
SGI-110: Day 5
|
11.1 ng/mL
Geometric Coefficient of Variation 65.8
|
30.7 ng/mL
Geometric Coefficient of Variation 42.5
|
45.2 ng/mL
Geometric Coefficient of Variation 43.4
|
72.7 ng/mL
Geometric Coefficient of Variation 41.1
|
120 ng/mL
Geometric Coefficient of Variation 31.7
|
205 ng/mL
Geometric Coefficient of Variation 34.9
|
173 ng/mL
Geometric Coefficient of Variation 36.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation: Maximum Observed Plasma Concentration (Cmax ) of SGI-110 and Decitabine
SGI-110: Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.7 ng/mL
Geometric Coefficient of Variation 60.7
|
18.1 ng/mL
Geometric Coefficient of Variation 99.3
|
66.3 ng/mL
Geometric Coefficient of Variation 63.8
|
107 ng/mL
Geometric Coefficient of Variation 40.0
|
118 ng/mL
Geometric Coefficient of Variation 27.8
|
187 ng/mL
Geometric Coefficient of Variation 40.9
|
—
|
|
Dose Escalation: Maximum Observed Plasma Concentration (Cmax ) of SGI-110 and Decitabine
Decitabine: Day 1
|
1.27 ng/mL
Geometric Coefficient of Variation 30.5
|
2.54 ng/mL
Geometric Coefficient of Variation 18.5
|
8.18 ng/mL
Geometric Coefficient of Variation 56.9
|
13.9 ng/mL
Geometric Coefficient of Variation 60.4
|
23.7 ng/mL
Geometric Coefficient of Variation 79.8
|
42.0 ng/mL
Geometric Coefficient of Variation 40.0
|
61.5 ng/mL
Geometric Coefficient of Variation 37.4
|
3.05 ng/mL
Geometric Coefficient of Variation 48.4
|
8.20 ng/mL
Geometric Coefficient of Variation 52.7
|
17.1 ng/mL
Geometric Coefficient of Variation 55.9
|
16.7 ng/mL
Geometric Coefficient of Variation 47.0
|
30.1 ng/mL
Geometric Coefficient of Variation 41.3
|
65.9 ng/mL
Geometric Coefficient of Variation 50.0
|
26.1 ng/mL
Geometric Coefficient of Variation 83.2
|
|
Dose Escalation: Maximum Observed Plasma Concentration (Cmax ) of SGI-110 and Decitabine
Decitabine: Day 5
|
1.67 ng/mL
Geometric Coefficient of Variation 54.7
|
3.52 ng/mL
Geometric Coefficient of Variation 27.4
|
10.3 ng/mL
Geometric Coefficient of Variation 65.1
|
16.7 ng/mL
Geometric Coefficient of Variation 37.6
|
22.7 ng/mL
Geometric Coefficient of Variation 69.9
|
53.6 ng/mL
Geometric Coefficient of Variation 37.4
|
59.1 ng/mL
Geometric Coefficient of Variation 30.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation: Maximum Observed Plasma Concentration (Cmax ) of SGI-110 and Decitabine
Decitabine: Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.78 ng/mL
Geometric Coefficient of Variation 43.8
|
6.92 ng/mL
Geometric Coefficient of Variation 79.5
|
12.7 ng/mL
Geometric Coefficient of Variation 41.8
|
19.0 ng/mL
Geometric Coefficient of Variation 55.8
|
35.0 ng/mL
Geometric Coefficient of Variation 45.4
|
53.2 ng/mL
Geometric Coefficient of Variation 39.5
|
—
|
SECONDARY outcome
Timeframe: Days 5 and 8Population: PK analysis set included all available plasma concentrations and PK parameters for guadecitabine and decitabine for participants who received study drug. Overall number of participants analyzed are the number of participants available for analysis. Number analyzed are the number of participants with data available for analysis at the given timepoint.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=4 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=4 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=5 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=7 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=12 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=5 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=3 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
n=4 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
n=8 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Minimum Observed Plasma Concentration (Cmin)
SGI-110: Day 5
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below lower limit of quantitation (LLOQ)
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation: Minimum Observed Plasma Concentration (Cmin)
SGI-110: Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA ng/mL
Geometric Coefficient of Variation 224
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation 200
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
NA ng/mL
Geometric Coefficient of Variation NA
Data could not be estimable as the values were below LLOQ.
|
—
|
SECONDARY outcome
Timeframe: Days 1, 5 and 8Population: Pharmacokinetic (PK) analysis set included all available plasma concentrations and PK parameters for guadecitabine and decitabine for participants who received study drug. Overall number of participants analyzed are the number of participants available for analysis. Number analyzed are the number of participants with data available for analysis at the given timepoint.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=3 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=4 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=5 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=7 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=12 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=2 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
n=5 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
n=6 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
n=7 Participants
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
n=6 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Area Under the Curve to Infinity (AUC0-inf)
SGI-110: Day 1
|
12.1 ng*hr/mL
Geometric Coefficient of Variation 71.5
|
45.2 ng*hr/mL
Geometric Coefficient of Variation 23.9
|
102 ng*hr/mL
Geometric Coefficient of Variation 42.7
|
211 ng*hr/mL
Geometric Coefficient of Variation 55.8
|
410 ng*hr/mL
Geometric Coefficient of Variation 25.8
|
528 ng*hr/mL
Geometric Coefficient of Variation 26.8
|
648 ng*hr/mL
Geometric Coefficient of Variation 31.3
|
21.4 ng*hr/mL
Geometric Coefficient of Variation 65.4
|
99.8 ng*hr/mL
Geometric Coefficient of Variation 25.2
|
182 ng*hr/mL
Geometric Coefficient of Variation 19.5
|
327 ng*hr/mL
Geometric Coefficient of Variation 48.9
|
331 ng*hr/mL
Geometric Coefficient of Variation 23.1
|
636 ng*hr/mL
Geometric Coefficient of Variation 40.2
|
328 ng*hr/mL
Geometric Coefficient of Variation 38.4
|
|
Dose Escalation: Area Under the Curve to Infinity (AUC0-inf)
SGI-110: Day 5
|
26.5 ng*hr/mL
Geometric Coefficient of Variation 5.87
|
63.5 ng*hr/mL
Geometric Coefficient of Variation 13.7
|
112 ng*hr/mL
Geometric Coefficient of Variation 29.8
|
226 ng*hr/mL
Geometric Coefficient of Variation 35.0
|
354 ng*hr/mL
Geometric Coefficient of Variation 13.8
|
423 ng*hr/mL
Geometric Coefficient of Variation 46.0
|
658 ng*hr/mL
Geometric Coefficient of Variation 26.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation: Area Under the Curve to Infinity (AUC0-inf)
SGI-110: Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17.9 ng*hr/mL
Geometric Coefficient of Variation 42.1
|
58.0 ng*hr/mL
Geometric Coefficient of Variation 15.0
|
227 ng*hr/mL
Geometric Coefficient of Variation 50.5
|
371 ng*hr/mL
Geometric Coefficient of Variation 15.2
|
383 ng*hr/mL
Geometric Coefficient of Variation 27.4
|
675 ng*hr/mL
Geometric Coefficient of Variation 45.1
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 38 months)Population: Efficacy analysis set included Regimen 1, 2A, 2B, r/r MDS and TN MDS participants who received at least one dose of study drug.
Time to AML or death was defined as the number of days from the date the subject received the first dose of guadecitabine (C1D1) to the date of death or the date of MDS/ chronic myelomonocytic leukemia (CMML) progression to AML, whichever occurred earlier. Time to AML or death was evaluated using the Kaplan-Meier method, with the time censored on the last date of contact if a participant was still alive without progression to AML.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=44 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=35 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=26 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=27 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=22 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and DE Phase- r/r MDS, TN MDS: Time to AML or Death
|
244.5 days
Interval 165.0 to 581.0
|
275.0 days
Interval 197.0 to 585.0
|
373.0 days
Interval 212.0 to
Upper limit of full range was not estimable due to insufficient number of participants with events.
|
273 days
Interval 164.0 to 622.0
|
276 days
Interval 175.0 to 436.0
|
680 days
Interval 402.0 to 848.0
|
542.5 days
Interval 224.0 to
Upper limit of full range was not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 45 months)Population: Efficacy analysis set included participants who received at least one dose of study drug.
OS was defined as the number of days from the day the participant received the first dose of guadecitabine to the date of death (regardless of cause).
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=44 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=35 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=50 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=53 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
n=26 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
n=22 Participants
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation and DE Phases- r/r AML, TN AML, r/r MDS, TN MDS: Overall Survival
|
124 days
Interval 82.0 to 181.0
|
186.5 days
Interval 115.0 to 236.0
|
212.0 days
Interval 111.0 to 304.0
|
172 days
Interval 142.0 to 254.0
|
214 days
Interval 169.0 to 269.0
|
—
|
—
|
—
|
—
|
273 days
Interval 199.0 to 622.0
|
370 days
Interval 253.0 to 447.0
|
771 days
Interval 460.0 to 1017.0
|
558 days
Interval 269.0 to
Upper limit of full range was not estimable due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 through 30 days after the last dose of study drug (up to approximately 46 months)Population: Efficacy analysis set included all participants who received at least one dose of study drug. Overall number of participants are the number of participants with data available for analysis.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=23 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=16 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=8 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Escalation: Number of Participants Achieving Blood and Platelet Transfusions
(Maintaining/achieving platelet transfusion independence)
|
100 percentage of participants
|
89 percentage of participants
|
75 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Dose Escalation: Number of Participants Achieving Blood and Platelet Transfusions
(Maintaining/achieving RBC transfusion independence)
|
100 percentage of participants
|
79 percentage of participants
|
89 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 45 months)Population: Efficacy analysis set included r/r AML and TN AML participants who received at least one dose of study drug.
CR is defined absolute neutrophil count (ANC) \>1.0×109/L, Platelets ≥100×109/L, independence from RBC and platelet transfusions over the past week, no myeloblasts and \<5% myeloblasts in bone marrow. CRp is defined ANC \>1.0×10\^9/L, Platelets \<100×10\^9/L, independence from RBC transfusions over the past week, no myeloblasts and \<5% myeloblasts in bone marrow. CRi is defined as ANC \<1.0×10\^9/L, no myeloblasts and \<5% myeloblasts in bone marrow. PR is defined as ANC \>1.0×10\^9/L, Platelets ≥100×10\^9/L, no myeloblasts and Decrease of ≥50% in myeloblasts to level of 5% to 25% in bone marrow.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=24 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=26 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=53 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=27 Participants
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=52 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DE Phase- r/r AML, TN AML: Percentage of Participants With Cr, CRp and PR
CR
|
8.3 percentage of participants
|
7.7 percentage of participants
|
18.9 percentage of participants
|
37.5 percentage of participants
|
40.7 percentage of participants
|
32.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
DE Phase- r/r AML, TN AML: Percentage of Participants With Cr, CRp and PR
CRi
|
4.2 percentage of participants
|
11.5 percentage of participants
|
3.8 percentage of participants
|
16.7 percentage of participants
|
11.1 percentage of participants
|
7.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
DE Phase- r/r AML, TN AML: Percentage of Participants With Cr, CRp and PR
CRp
|
0 percentage of participants
|
0 percentage of participants
|
7.5 percentage of participants
|
0 percentage of participants
|
7.4 percentage of participants
|
9.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
DE Phase- r/r AML, TN AML: Percentage of Participants With Cr, CRp and PR
PR
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
4.2 percentage of participants
|
3.7 percentage of participants
|
1.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At end of each Cycle of 28 days (Up to approximately 45 months)Population: Efficacy analysis set included r/r MDS and TN MDS participants who received at least one dose of study drug. Overall number of participants are the number of participants with data available for analysis.
CR is defined ANC \>1.0×109/L, Platelets ≥100×109/L, independence from RBC and platelet transfusions over the past week, no myeloblasts and \<5% myeloblasts in bone marrow. CRp is defined ANC \>1.0×10\^9/L, Platelets \<100×10\^9/L, independence from RBC transfusions over the past week, no myeloblasts and \<5% myeloblasts in bone marrow. CRi is defined as ANC \<1.0×10\^9/L, no myeloblasts and \<5% myeloblasts in bone marrow. PR is defined as ANC \>1.0×10\^9/L, Platelets ≥100×10\^9/L, no myeloblasts and Decrease of ≥50% in myeloblasts to level of 5% to 25% in bone marrow.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=26 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=27 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=27 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=22 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DE Phase- r/r MDS, TN MDS: Percentage of Participants With CR, PR, mCR and HI
CR+PR+mCR
|
19 percentage of participants
|
44 percentage of participants
|
26 percentage of participants
|
50 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
DE Phase- r/r MDS, TN MDS: Percentage of Participants With CR, PR, mCR and HI
HI
|
23 percentage of participants
|
33 percentage of participants
|
44 percentage of participants
|
41 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 8 and 16Population: Efficacy analysis set included r/r MDS and TN MDS participants who received at least one dose of study drug. Overall Number of Participants Analyzed are those who were dependent on RBC transfusions at baseline.
Transfusion dependence at baseline was defined as any transfusion within 4 weeks of the first study dose (C1D1) with C1D1 transfusion counted, assuming it was always done before dosing. Transfusion independence after treatment was defined as no transfusion within an 8-week or 16-week period between C1D1 and last treatment date + 30 days.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=16 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=18 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=9 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DE Phase- r/r MDS, TN MDS: Number of Participants Achieving Blood Transfusion Independence for 8 or 16-weeks
RBC Independence for Week 8
|
1 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
DE Phase- r/r MDS, TN MDS: Number of Participants Achieving Blood Transfusion Independence for 8 or 16-weeks
RBC Independence for Week 16
|
0 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 8 and 16Population: Efficacy analysis set included r/r MDS and TN MDS participants who received at least one dose of study drug. Overall Number of Participants Analyzed are those who were dependent on platelet transfusions at baseline.
Transfusion dependence at baseline was defined as any transfusion within 4 weeks of the first study dose (C1D1) with C1D1 transfusion counted, assuming it was always done before dosing. Transfusion independence after treatment was defined as no transfusion within an 8-week or 16-week period between C1D1 and last treatment date + 30 days.
Outcome measures
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=6 Participants
Participants received starting dose of guadecitabine 3 mg/m\^2, SC, daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=10 Participants
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=7 Participants
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=5 Participants
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5, SC of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Escalation: Regimen 2B: Twice Weekly - 60 mg/m^2
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
DE Phase- r/r MDS, TN MDS: Number of Participants Achieving Platelet Transfusion Independence for 8 or 16-weeks
Platelet Independence for Week 8
|
0 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
DE Phase- r/r MDS, TN MDS: Number of Participants Achieving Platelet Transfusion Independence for 8 or 16-weeks
Platelet Independence for Week 16
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
Serious events: 33 serious events
Other events: 44 other events
Deaths: 5 deaths
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
Serious events: 28 serious events
Other events: 34 other events
Deaths: 4 deaths
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (5-Day)
Serious events: 19 serious events
Other events: 24 other events
Deaths: 4 deaths
Dose Expansion: r/r AML Guadecitabine 90 mg/m^2 (5-Day)
Serious events: 21 serious events
Other events: 26 other events
Deaths: 3 deaths
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (10-Day)
Serious events: 44 serious events
Other events: 53 other events
Deaths: 10 deaths
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
Serious events: 21 serious events
Other events: 24 other events
Deaths: 4 deaths
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
Serious events: 24 serious events
Other events: 27 other events
Deaths: 7 deaths
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
Serious events: 45 serious events
Other events: 52 other events
Deaths: 11 deaths
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
Serious events: 17 serious events
Other events: 26 other events
Deaths: 2 deaths
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
Serious events: 22 serious events
Other events: 27 other events
Deaths: 4 deaths
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
Serious events: 17 serious events
Other events: 27 other events
Deaths: 1 deaths
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
Serious events: 17 serious events
Other events: 22 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=44 participants at risk
Participants received starting dose of guadecitabine 3 milligrams per meter square (mg/m\^2), subcutaneously (SC), daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=34 participants at risk
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15 of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 participants at risk
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily,from Days 1-5 of a 28-day cycle in participants with diagnosis of relapsed/refractory (r/r) AML.
|
Dose Expansion: r/r AML Guadecitabine 90 mg/m^2 (5-Day)
n=26 participants at risk
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (10-Day)
n=53 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, dailyfrom Days 1-5, SC of a 28-day cycle in participants with a diagnosis of treatment naïve (TN) AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=27 participants at risk
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=52 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
n=26 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r Myelodysplastic Syndromes (MDS).
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
n=27 participants at risk
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
n=27 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
n=22 participants at risk
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
29.5%
13/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
32.4%
11/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
5/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.5%
9/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
38.5%
10/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
52.8%
28/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
50.0%
12/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
55.6%
15/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
48.1%
25/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
34.6%
9/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
40.7%
11/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
40.9%
9/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Pneumonia
|
34.1%
15/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.5%
8/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
34.6%
9/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
32.1%
17/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.0%
10/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
30.8%
16/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.0%
10/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Sepsis
|
18.2%
8/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.6%
6/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
11/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.9%
14/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.6%
3/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Cellulitis
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Bacteraemia
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Hypotension
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Multi-organ failure
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Renal failure acute
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Anorectal infection
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Pyrexia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Asthenia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Septic shock
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Eye pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Syncope
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Fatigue
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
Other adverse events
| Measure |
Dose Escalation: Regimen 1 - Guadecitabine 3 mg/m^2 Daily
n=44 participants at risk
Participants received starting dose of guadecitabine 3 milligrams per meter square (mg/m\^2), subcutaneously (SC), daily from Days 1-5 of a 28-day cycle. The dose was subsequently increased to 9, 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2A - Guadecitabine 6 mg/m^2 Once Weekly
n=34 participants at risk
Participants received starting dose of guadecitabine 6 mg/m\^2, SC, once weekly on Days 1, 8 and 15 of a 28-day cycle. The dose was subsequently increased to 18, 36, 60, 90, 125 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Escalation: Regimen 2B - Guadecitabine 60 mg/m^2 Twice Weekly
n=15 participants at risk
Participants received starting dose of guadecitabine 60 mg/m\^2, SC, twice weekly on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle. The dose was subsequently increased to 90 mg/m\^2 for subsequent cycles until development of toxicity or disease progression.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily,from Days 1-5 of a 28-day cycle in participants with diagnosis of relapsed/refractory (r/r) AML.
|
Dose Expansion: r/r AML Guadecitabine 90 mg/m^2 (5-Day)
n=26 participants at risk
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: r/r AML Guadecitabine 60 mg/m^2 (10-Day)
n=53 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of r/r AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (5-Day)
n=24 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, dailyfrom Days 1-5, SC of a 28-day cycle in participants with a diagnosis of treatment naïve (TN) AML.
|
Dose Expansion: TN AML Guadecitabine 90 mg/m^2 (5-Day)
n=27 participants at risk
Participants received guadecitabine 90 mg/m\^2, SC, daily, from Days 1-5of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: TN AML Guadecitabine 60 mg/m^2 (10-Day)
n=52 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily, from Days 1-5 and 8-12of a 28-day cycle in participants with a diagnosis of TN AML.
|
Dose Expansion: r/r MDS Guadecitabine 60 mg/m^2 (5-Day)
n=26 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of r/r Myelodysplastic Syndromes (MDS).
|
Dose Expansion: r/r MDS Guadecitabine 90 mg/m^2 (5-Day)
n=27 participants at risk
Participants received guadecitabine 90 mg/m\^2, SC, daily on Days 1-5of a 28-day cycle in participants with a diagnosis of r/r MDS.
|
Dose Expansion: TN MDS Guadecitabine 60 mg/m^2 (5-Day)
n=27 participants at risk
Participants received guadecitabine 60 mg/m\^2, SC, daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
Dose Expansion: TN MDS Guadecitabine 90 mg/m^2 (5-Day)
n=22 participants at risk
Participants received guadecitabine 90 mg/m\^2, SC. daily on Days 1-5 of a 28-day cycle in participants with a diagnosis of TN MDS.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
11/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.5%
8/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
5/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.1%
6/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
52.8%
28/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
45.8%
11/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.0%
10/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.9%
14/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
57.7%
15/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
48.1%
13/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
40.7%
11/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
59.1%
13/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.1%
8/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
42.3%
11/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
24.5%
13/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.1%
4/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.6%
6/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.5%
9/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.7%
4/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
28.3%
15/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.5%
9/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
44.4%
12/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
34.6%
18/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
53.8%
14/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
44.4%
12/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
40.7%
11/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
63.6%
14/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.8%
14/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.6%
6/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.7%
4/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
5/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
49.1%
26/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
54.2%
13/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
44.4%
12/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
46.2%
24/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
53.8%
14/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
51.9%
14/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
9/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
54.5%
12/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Atrial thrombosis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Tachycardia
|
9.1%
4/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Auricular swelling
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Dry eye
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Eye irritation
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Vision blurred
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.6%
12/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Anal fissure
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Ascites
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
8/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.6%
6/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
34.6%
9/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
41.5%
22/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
50.0%
12/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
51.9%
14/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
61.5%
32/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
5/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.0%
10/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
54.5%
12/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
22/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
32.4%
11/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
34.6%
9/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
52.8%
28/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
41.7%
10/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
44.4%
12/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
59.6%
31/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.9%
7/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
55.6%
15/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.0%
10/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
31.8%
7/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.5%
7/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.3%
6/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gingival erythema
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gingival pain
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gingival swelling
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Glossodynia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Haematemesis
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Lip dry
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Melaena
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
12/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.5%
9/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
5/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
58.5%
31/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
45.8%
11/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
48.1%
13/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
50.0%
26/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
38.5%
10/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.6%
8/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.6%
8/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
54.5%
12/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Oesophageal pain
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Oesophagitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Oral disorder
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Oral mucosal discolouration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Stomatitis
|
13.6%
6/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
35.8%
19/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
9/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
28.8%
15/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
40.7%
11/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
31.8%
7/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Stomatitis necrotising
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Vomiting
|
22.7%
10/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.7%
5/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
39.6%
21/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
30.8%
16/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
40.9%
9/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Asthenia
|
9.1%
4/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.6%
7/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.1%
8/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
36.5%
19/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
5/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
27.3%
6/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Catheter site erythema
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Catheter site pain
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Candidiasis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Chest discomfort
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Chest pain
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Chills
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.7%
5/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
27.3%
6/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Device occlusion
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Face oedema
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Fatigue
|
25.0%
11/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.5%
9/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
46.7%
7/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.2%
7/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
34.6%
9/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
49.1%
26/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
45.8%
11/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.0%
10/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
40.4%
21/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
42.3%
11/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.0%
10/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
44.4%
12/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
40.9%
9/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Gait disturbance
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Generalised oedema
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Infusion site induration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site discomfort
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site haematoma
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.7%
5/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site haemorrhage
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site mass
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site nodule
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.6%
8/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site pain
|
25.0%
11/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
32.4%
11/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
60.0%
9/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.2%
7/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
34.6%
9/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
34.0%
18/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
45.8%
11/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
59.3%
16/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
30.8%
8/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
9/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
40.7%
11/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
54.5%
12/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site reaction
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.3%
6/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.5%
7/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Localised oedema
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Oedema
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.1%
12/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Oedema peripheral
|
25.0%
11/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.5%
9/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
30.2%
16/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
8/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.0%
10/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
28.8%
15/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
30.8%
8/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
13/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Pyrexia
|
15.9%
7/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.5%
8/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.1%
8/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.3%
9/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.6%
3/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Systemic inflammatory response syndrome
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Hepatobiliary disorders
Cholecystitis
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Hepatobiliary disorders
Hepatomegaly
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Immune system disorders
Drug hypersensitivity
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Immune system disorders
Hypersensitivity
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Immune system disorders
Immune system disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Immune system disorders
Seasonal allergy
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Abscess jaw
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Acute haemorrhagic conjunctivitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Acute sinusitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Cellulitis
|
15.9%
7/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.1%
8/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.9%
14/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.7%
5/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Cystitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Device related infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Ear infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Enterococcal bacteraemia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Fungal skin infection
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Influenza
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Lip infection
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Immune system disorders
Mastoiditis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Oral candidiasis
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.3%
6/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Oral fungal infection
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Oral herpes
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Otitis media
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Parotitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Pneumonia
|
18.2%
8/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
28.3%
15/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
8/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Rhinitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Sialoadenitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Sinusitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Staphylococcal infection
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Streptococcal urinary tract infection
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Tooth abscess
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Tooth infection
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.7%
5/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Urethritis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Urinary tract infection
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.7%
5/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.1%
8/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Vaginal infection
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Wound infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Contusion
|
13.6%
6/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.1%
8/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
8/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
21.2%
11/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
34.6%
9/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
27.3%
6/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
10/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Open wound
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Underdose
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Activated partial thromboplastin time
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood creatinine increased
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood magnesium increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood potassium increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood urine present
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Breath sounds abnormal
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Cardiac murmur
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Electrocardiogram qt prolonged
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Fibrinolysis increased
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Hepatic enzyme increased
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Occult blood positive
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Transaminases increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Weight decreased
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.2%
7/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
White blood cell count increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.5%
9/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.7%
4/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.1%
6/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
47.2%
25/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
8/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
51.9%
14/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
38.5%
20/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
30.8%
8/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.6%
8/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
31.8%
7/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
4/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.7%
5/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Fluid retention
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.6%
6/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.7%
5/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.1%
6/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.6%
6/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.2%
7/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
4/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.5%
9/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.5%
9/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
42.3%
11/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
47.2%
25/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.5%
9/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
51.9%
14/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
51.9%
27/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.6%
8/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
27.3%
6/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.6%
6/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
30.8%
8/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
50.9%
27/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.6%
8/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
44.2%
23/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
9/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.6%
6/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
8/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.6%
3/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.6%
6/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.3%
6/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
8/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
5/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.6%
3/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
4/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.9%
10/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.1%
12/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.6%
3/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.3%
6/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.9%
7/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.5%
7/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.6%
8/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.7%
5/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acanthoma
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Aphasia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Consciousness fluctuating
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Dementia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Dizziness
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
29.6%
8/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.9%
14/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.9%
7/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
4/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Headache
|
20.5%
9/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.6%
6/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
24.5%
13/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
8/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
31.8%
7/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Hypoaesthesia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Lethargy
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Pachymeningitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Peroneal nerve palsy
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Sinus headache
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Somnolence
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Syncope
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Tremor
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Agitation
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.1%
8/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.9%
14/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Depression
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
11/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
5/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Hallucination, visual
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Insomnia
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.5%
8/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.9%
10/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.1%
6/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
36.4%
8/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Mental status changes
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.3%
6/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Psychotic disorder
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Restlessness
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Micturition urgency
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Nocturia
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Oliguria
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Pollakiuria
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Renal failure
|
11.4%
5/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Renal failure acute
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Renal impairment
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Breast mass
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
12/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.5%
9/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.9%
7/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
41.5%
22/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.5%
9/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
38.5%
20/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
30.8%
8/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
37.0%
10/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.7%
5/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
11/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
32.4%
11/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.0%
9/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
6/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
44.4%
12/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
50.0%
26/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
31.8%
7/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
11/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.1%
6/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.1%
8/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
13/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.1%
6/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.9%
7/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.2%
8/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.1%
8/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal blistering
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
4/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.0%
9/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
25.0%
13/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus mucosal hypertrophy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
8/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.5%
7/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord cyst
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.8%
3/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
21.2%
11/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.6%
3/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.1%
4/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.6%
6/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
17.3%
9/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
4/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
8/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.7%
5/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
13.6%
6/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.3%
6/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
23.1%
6/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.6%
3/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
6/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.2%
4/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Pruritus generalised
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.9%
7/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
26.5%
9/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.0%
3/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
20.8%
11/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
21.2%
11/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
33.3%
9/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.7%
5/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.5%
2/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
6.7%
1/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Surgical and medical procedures
Sinus operation
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
2.9%
1/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Surgical and medical procedures
Vagotomy
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Capillary leak syndrome
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Haematoma
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.9%
2/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.5%
5/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Hypertension
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.8%
3/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.4%
5/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Hypotension
|
22.7%
10/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.8%
4/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.3%
2/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
16.7%
4/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
5/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.9%
10/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
10/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
14.8%
4/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Pallor
|
2.3%
1/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
External ear disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Cataract
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Eye pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Eye swelling
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Keratopathy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Photophobia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Scleral disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Scotoma
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Visual impairment
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Axillary pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Cyst
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Feeling cold
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site erythema
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site inflammation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site swelling
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Malaise
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Mucosal dryness
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Nodule
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Swelling
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Abscess
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Bk virus infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Epstein-barr viraemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Fusarium infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Gingival infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Impetigo
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Injection site infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Mycobacterium kansasii infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Paronychia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Pericoronitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Puncture site infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Sepsis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Sweating fever
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Tracheostomy infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
13.6%
3/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.5%
4/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood amylase increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood creatine increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood glucose increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood urea increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Lipase increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Sputum culture
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Troponin i increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
10/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.1%
2/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-barr virus associated lymphoproliferative disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
15.4%
4/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
18.9%
10/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.3%
6/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Vulvar erosion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.5%
3/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Facial wasting
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
11.1%
3/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Surgical and medical procedures
Enterostomy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Surgical and medical procedures
Maxillofacial operation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
9.6%
5/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.7%
3/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
5.8%
3/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Endocrine disorders
Goitre
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Blepharitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Conjunctival pallor
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Keratitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Pupillary disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Scleral pigmentation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Infusion site reaction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site joint redness
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Mass
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Ulcer
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Genital abscess
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Oral infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Viral infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Rib fracture
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Subdural haematoma
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Aspergillus test positive
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Enterobacter test positive
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Platelet count decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Weight increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Alkalosis hypochloraemic
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Diabetes mellitus
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
12.5%
3/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Sedation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
8.3%
2/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
22.2%
6/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
19.2%
10/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Delirium febrile
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
2/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Surgical and medical procedures
Nail operation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.2%
1/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
1.9%
1/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.7%
2/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Chalazion
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Conjunctival discolouration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Conjunctival irritation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Crepitations
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Hernia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Induration
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Inflammation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Influenza like illness
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Infusion site pain
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site joint swelling
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site pruritus
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Injection site rash
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Secretion discharge
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Tenderness
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
General disorders
Thirst
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Coccidioidomycosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Furuncle
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Hepatitis c
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Infected sebaceous cyst
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Nail infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Nasal abscess
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Orchitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Periorbital infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Conjunctival scar
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Bacterial test positive
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Investigations
Enterococcus test positive
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Haemosiderosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Metabolism and nutrition disorders
Weight fluctuation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Floating patella
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia cutis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Anhedonia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Circumoral oedema
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Cutis laxa
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Palpable purpura
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Perivascular dermatitis
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.7%
1/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Embolism
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Flushing
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
|
Vascular disorders
Hot flush
|
0.00%
0/44 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/34 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/15 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/53 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/24 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/52 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
3.8%
1/26 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
7.4%
2/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
0.00%
0/27 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
4.5%
1/22 • From first dose of study drug up to 30 days post study treatment (up to 46 months)
All-cause mortality is reported for all enrolled participants. Serious adverse events are reported for safety set which included data from all participants who received at least one dose of study drug. Reconciling the \>=5% adverse event data collected in multiple cohorts in trials conducted approximately 10 years ago cannot be provided as a single comprehensive data set, therefore no data is available to report for this safety section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place