Trial Outcomes & Findings for Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies (NCT NCT02457598)
NCT ID: NCT02457598
Last Updated: 2025-06-17
Results Overview
A DLT was defined as a ≥ Grade 3 AE that was assessed as related to study drug that occurred during the 28-day DLT assessment period with protocol-defined allowed exceptions. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
203 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2025-06-17
Participant Flow
Participants were enrolled at study sites in France, the United Kingdom and the United States.
248 participants were screened. 203 participants were enrolled, 197 participants were enrolled to receive treatment in Combinations I to IV and Group V. 5 participants rolled over from another tirabrutinib study (GS-US-401-1787) and 1 from this study (GS-US-401-1757) was re-assigned to Group VI to continue with tirabrutinib and be monitored for long-term safety. Per pre-specified analysis, participants in Group VI were analyzed based on the disease type.
Participant milestones
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
8
|
4
|
25
|
9
|
5
|
3
|
6
|
3
|
3
|
78
|
8
|
6
|
7
|
29
|
3
|
3
|
|
Overall Study
Rollover Participants
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
4
|
25
|
9
|
4
|
3
|
6
|
3
|
3
|
78
|
8
|
6
|
7
|
29
|
3
|
3
|
Reasons for withdrawal
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
2
|
2
|
1
|
11
|
7
|
3
|
2
|
1
|
1
|
2
|
45
|
6
|
2
|
2
|
10
|
1
|
1
|
|
Overall Study
Investigator's Discretion
|
0
|
2
|
2
|
2
|
0
|
0
|
0
|
1
|
2
|
0
|
10
|
2
|
2
|
1
|
5
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
1
|
0
|
4
|
1
|
0
|
1
|
0
|
0
|
0
|
4
|
0
|
1
|
0
|
8
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
4
|
1
|
0
|
0
|
1
|
0
|
1
|
6
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
1
|
2
|
0
|
1
|
|
Overall Study
Transition to the MHRA's Special Scheme
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
4
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Unacceptable Toxicity
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Intercurrent Illness
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies
Baseline characteristics by cohort
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=8 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=25 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=9 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=78 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=8 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=7 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib
n=29 Participants
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
n=3 Participants
Participants with CLL received tirabrutinib, at the original dose (20 - 160 mg), tablet QD, for each 28-day cycle up to 441 weeks.
|
Group VI Single Agent Tirabrutinib: NHL
n=3 Participants
Participants with NHL received tirabrutinib, at the original dose (20 - 160 mg), tablet QD, for each 28-day cycle up to 441 weeks.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
72 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
21 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
131 Participants
n=44 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
65 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
62 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
64 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
73 years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
55 years
STANDARD_DEVIATION 12.8 • n=8 Participants
|
70 years
STANDARD_DEVIATION 7.0 • n=8 Participants
|
66 years
STANDARD_DEVIATION 11.1 • n=24 Participants
|
67 years
STANDARD_DEVIATION 5.1 • n=42 Participants
|
67 years
STANDARD_DEVIATION 1.2 • n=42 Participants
|
68 years
STANDARD_DEVIATION 11.7 • n=42 Participants
|
63 years
STANDARD_DEVIATION 11.9 • n=42 Participants
|
59 years
STANDARD_DEVIATION 11.8 • n=36 Participants
|
64 years
STANDARD_DEVIATION 14.4 • n=36 Participants
|
70 years
STANDARD_DEVIATION 9.4 • n=24 Participants
|
66 years
STANDARD_DEVIATION 4.0 • n=135 Participants
|
74 years
STANDARD_DEVIATION 4.4 • n=136 Participants
|
67 years
STANDARD_DEVIATION 11.3 • n=44 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
75 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
53 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
17 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
128 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
23 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
154 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
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
|
27 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
48 Participants
n=44 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
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 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
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
21 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
134 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 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
|
30 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
62 Participants
n=44 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
83 Participants
n=44 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
83 Participants
n=44 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
37 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: The participants in the DLT Analysis Set with available data were analyzed. The DLT Analysis Set included all participants in the dose escalation, in Combination I, II, III, IV, who completed all treatment for at least 21 days within the first 28 days, or experienced a DLT prior to Day 28, inclusive.
A DLT was defined as a ≥ Grade 3 AE that was assessed as related to study drug that occurred during the 28-day DLT assessment period with protocol-defined allowed exceptions. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=4 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=3 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Dose Limiting Toxicities (DLTs)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Participants in the Full Analysis Set with non-CLL type of Non-Hodgkin's Lymphoma (NHL), were analyzed. The Full Analysis Set included all enrolled participants who took at least 1 dose of study drug. Group V did not have any participants with non-CLL type of NHL, therefore, no data is reported for this arm.
ORR for Waldenstrom Macroglobulinemia(WM):CR+VGPR+PR+MPR. CR: Absence of serum monoclonal IgM protein; normal serum IgM level: complete resolution of extramedullary disease, morphologically normal bone marrow/aspirate and trephine biopsy. Very good partial response (VGPR):Detectable monoclonal IgM; ≥90% reduction in serum IgM; Complete resolution of extramedullary disease; No new signs/symptoms. PR: Monoclonal immunoglobulin M (IgM) protein is detectable ≥50% but \<90% reduction in serum IgM level from baseline; reduction of extramedullary disease; no new signs or symptoms of active disease. Minor response (MPR):Detectable monoclonal IgM; ≥25% but \<50% reduction in serum IgM; No progression of extramedullary disease; No new signs/symptoms. Clopper-Pearson method was used in analysis. Data is reported by disease type: WM; Follicular Lymphoma (FL);Mantle Cell Lymphoma (MCL);Small Lymphocytic Lymphoma (SLL);Marginal Zone Lymphoma (MZL);Diffuse Large B-Cell Lymphoma (DLBCL) as applicable.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=19 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=9 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=71 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=8 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=7 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) at Week 12 in Participants With Non-Chronic Lymphocytic Leukemia (CLL) Type NHL
Disease Subtype: FL
|
—
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 97.5
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
—
|
0 percentage of participants
Interval 0.0 to 84.2
|
—
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
0 percentage of participants
Interval 0.0 to 97.5
|
18.2 percentage of participants
Interval 5.2 to 40.3
|
—
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
—
|
—
|
—
|
|
Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) at Week 12 in Participants With Non-Chronic Lymphocytic Leukemia (CLL) Type NHL
Disease Subtype: MCL
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) at Week 12 in Participants With Non-Chronic Lymphocytic Leukemia (CLL) Type NHL
Disease Subtype: SLL
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
—
|
—
|
—
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 84.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) at Week 12 in Participants With Non-Chronic Lymphocytic Leukemia (CLL) Type NHL
Disease Subtype: MZL
|
—
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
—
|
—
|
—
|
|
Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) at Week 12 in Participants With Non-Chronic Lymphocytic Leukemia (CLL) Type NHL
Disease Subtype: WM
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) at Week 12 in Participants With Non-Chronic Lymphocytic Leukemia (CLL) Type NHL
Disease Subtype: DLBCL
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
22.2 percentage of participants
Interval 2.8 to 60.0
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
17.9 percentage of participants
Interval 6.1 to 36.9
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Participants in the Full Analysis Set with CLL were analyzed. There were 5 arms in Combinations I and II that did not have participants with CLL type of NHL. Also, Combinations III and IV did not have any participants with CLL type of NHL, therefore, no data is reported for these arms.
ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR). CR and PR are defined in outcome measure#2. Clopper-Pearson method was used in outcome measure analysis. Percentages were rounded off.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=1 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=1 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=1 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=7 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
n=29 Participants
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ORR: Percentage of Participants With CR or PR in Participants With CLL at Week 24
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
—
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
—
|
—
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
—
|
—
|
—
|
79.3 percentage of participants
Interval 60.3 to 92.0
|
—
|
—
|
PRIMARY outcome
Timeframe: First dose up to last dose date (up to 441 weeks) plus 30 daysPopulation: The Safety Analysis Set included all participants who took at least 1 dose of any study drug.
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. TEAEs were defined as an AE that onset in the period from the first dose of study treatment to 30 days after the last dose of study treatment. Percentages were rounded off.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=8 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=25 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=9 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=78 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=8 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=7 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
n=29 Participants
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
n=3 Participants
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
n=3 Participants
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
75.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 281 weeksPopulation: Participants in the Full Analysis Set were analyzed.
ORR for WM is CR + VGPR + PR + MPR. CR, PR, VGPR and MPR are defined in outcome measure#2. Clopper-Pearson method was used in outcome measure analysis. Percentages were rounded off. Data is reported by disease type: CLL ; FL; MCL; MZL; SLL; WM; DLBCL.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=8 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=25 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=9 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=78 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=8 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=7 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
n=29 Participants
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ORR: Percentage of Participants With Complete Response (CR) or Partial Response (PR) in the Dose Escalation and Expansion Phase
Disease Subtype: DLBCL
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
25.0 percentage of participants
Interval 10.7 to 44.9
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
—
|
—
|
—
|
—
|
—
|
|
ORR: Percentage of Participants With Complete Response (CR) or Partial Response (PR) in the Dose Escalation and Expansion Phase
Disease Subtype: CLL
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 47.8 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
—
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
—
|
—
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
—
|
—
|
—
|
86.2 percentage of participants
Interval 68.3 to 96.1
|
—
|
—
|
|
ORR: Percentage of Participants With Complete Response (CR) or Partial Response (PR) in the Dose Escalation and Expansion Phase
Disease Subtype: FL
|
—
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 97.5
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
—
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
—
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
36.4 percentage of participants
Interval 17.2 to 59.3
|
—
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
—
|
—
|
—
|
|
ORR: Percentage of Participants With Complete Response (CR) or Partial Response (PR) in the Dose Escalation and Expansion Phase
Disease Subtype: MCL
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
—
|
—
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
70.0 percentage of participants
Interval 34.8 to 93.3
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
—
|
—
|
—
|
—
|
|
ORR: Percentage of Participants With Complete Response (CR) or Partial Response (PR) in the Dose Escalation and Expansion Phase
Disease Subtype: MZL
|
—
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
—
|
—
|
—
|
|
ORR: Percentage of Participants With Complete Response (CR) or Partial Response (PR) in the Dose Escalation and Expansion Phase
Disease Subtype: SLL
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
—
|
—
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
ORR: Percentage of Participants With Complete Response (CR) or Partial Response (PR) in the Dose Escalation and Expansion Phase
Disease Subtype: WM
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
—
|
0 percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 281 weeksPopulation: The participants in the Full Analysis Set were analyzed. For Cohort III and IV, data for PFS was not available by disease type due to low number of participants with events. Data is reported together for all participants in Other NHL category.
PFS was defined as the interval from the start of the study therapy to the earlier of the first documentation of definite disease progression (PD) or death from any cause. PD: ≥ 25% increase in serum IgM level from lowest nadir (requires confirmation) and/or progression in clinical features attributable to the disease. Kaplan-Meier (KM) estimate were used in outcome measure analysis. Data is reported by disease type: CLL; FL; MCL; MZL; other NHL; DLBCL.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=8 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=25 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=9 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=78 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=8 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=7 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
n=29 Participants
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: CLL
|
NA months
Median, Lower and Upper limit of Confidence interval (CI), were not estimable due to low number of participants with events.
|
NA months
Interval 20.8 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
31.8 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Interval 8.3 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
39.6 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
|
Progression Free Survival (PFS) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: DLBCL
|
—
|
—
|
1.4 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
1.5 months
Interval 1.1 to 5.0
|
2.5 months
Interval 1.2 to 11.0
|
—
|
—
|
1.2 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
2.8 months
Interval 1.5 to 5.3
|
2.3 months
Interval 1.4 to 4.1
|
—
|
—
|
—
|
—
|
—
|
|
Progression Free Survival (PFS) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: FL
|
—
|
8.2 months
Interval 5.3 to 11.1
|
5.3 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
5.6 months
Interval 1.0 to
Upper limit of CI was not estimable due to low number of participants with events.
|
—
|
12.3 months
Interval 5.4 to 19.3
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
19.4 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
19.4 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
11.0 months
Interval 5.1 to 21.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Progression Free Survival (PFS) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: MCL
|
—
|
21.6 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
5.4 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
27.6 months
Interval 16.8 to
Upper limit of CI was not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Progression Free Survival (PFS) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: other NHL
|
13.7 months
Interval 5.5 to 21.9
|
—
|
6.0 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Interval 2.5 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
2.6 months
Interval 1.2 to 4.0
|
56.9 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
NA months
Interval 6.6 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Interval 8.6 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
NA months
Interval 5.6 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Interval 5.4 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 281 weeksPopulation: Participants in the Full Analysis Set with ORR were analyzed.
DOR was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definite disease progression or death from any cause. CR and PR are defined in outcome measure# 2. PD is defined in outcome measure #6. KM estimates were used in outcome measure analysis. Data is reported by disease type: CLL; FL; MCL; MZL; SLL; WM; DLBCL
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=6 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=12 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=2 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=2 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=37 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=1 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=5 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
n=25 Participants
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: DLBCL
|
—
|
—
|
—
|
3.9 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Interval 6.4 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
8.3 months
Interval 1.4 to 23.5
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response (DOR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: CLL
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Interval 15.2 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
26.5 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
34.1 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
|
Duration of Response (DOR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: FL
|
—
|
—
|
—
|
3.0 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
13.8 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
16.6 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
6.3 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
17.3 months
Interval 2.3 to
Upper limit of CI was not estimable due to low number of participants with events.
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Interval 4.4 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
|
Duration of Response (DOR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: MCL
|
—
|
10.7 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24.9 months
Interval 14.0 to
Upper limit of CI was not estimable due to low number of participants with events.
|
—
|
2.8 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
|
Duration of Response (DOR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: SLL
|
19.3 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
51.4 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response (DOR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: MZL
|
—
|
—
|
3.3 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
2.5 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
8.2 months
Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
|
Duration of Response (DOR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: WM
|
—
|
—
|
—
|
NA months
Interval 20.1 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
NA months
Median, Lower and Upper limit of CI were not estimable due to low number of participants with events.
|
NA months
Interval 13.9 to
Median and Upper limit of CI were not estimable due to low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 281 weeksPopulation: Participants in the Full Analysis Set with ORR were analyzed.
TTR was defined as the interval from start of treatment to the first documentation of CR or PR. CR and PR are defined in outcome measure# 2. Data is reported by disease type: CLL; FL; MCL; MZL; SLL; WM; DLBCL.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=6 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=12 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=2 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=2 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=37 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=1 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=5 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
n=25 Participants
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: DLBCL
|
—
|
—
|
—
|
1.6 months
Interval 1.6 to 1.6
|
1.8 months
Interval 1.4 to 4.6
|
—
|
—
|
—
|
1.9 months
Interval 1.1 to 2.8
|
—
|
1.5 months
Interval 1.3 to 13.0
|
1.6 months
Interval 1.6 to 1.6
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: CLL
|
2.7 months
Interval 2.7 to 2.7
|
5.6 months
Interval 5.4 to 5.8
|
5.4 months
Interval 5.4 to 5.4
|
5.6 months
Interval 4.6 to 8.0
|
—
|
5.6 months
Interval 5.6 to 5.6
|
—
|
5.4 months
Interval 4.4 to 5.9
|
—
|
—
|
5.9 months
Interval 5.4 to 6.8
|
—
|
—
|
—
|
5.5 months
Interval 2.7 to 5.9
|
—
|
—
|
|
Time to Response (TTR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: FL
|
—
|
—
|
—
|
2.6 months
Interval 2.6 to 2.6
|
—
|
5.5 months
Interval 5.5 to 5.5
|
—
|
2.8 months
Interval 2.8 to 2.8
|
2.8 months
Interval 2.8 to 2.8
|
13.0 months
Interval 13.0 to 13.0
|
3.7 months
Interval 2.8 to 11.0
|
—
|
3.9 months
Interval 2.6 to 9.2
|
2.9 months
Interval 2.6 to 4.6
|
—
|
—
|
—
|
|
Time to Response (TTR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: MCL
|
—
|
10.8 months
Interval 10.8 to 10.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.8 months
Interval 2.8 to 8.4
|
—
|
2.8 months
Interval 2.8 to 2.8
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: SLL
|
2.7 months
Interval 2.7 to 2.7
|
—
|
—
|
—
|
—
|
—
|
5.5 months
Interval 5.4 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Response (TTR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: MZL
|
—
|
—
|
2.8 months
Interval 2.8 to 2.8
|
2.9 months
Interval 2.9 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
2.7 months
Interval 2.7 to 2.8
|
—
|
2.7 months
Interval 2.7 to 2.7
|
2.8 months
Interval 2.8 to 2.8
|
—
|
—
|
—
|
|
Time to Response (TTR) During the Dose Escalation Phase and Dose Expansion Phase
Disease Subtype: WM
|
—
|
—
|
—
|
2.8 months
Interval 2.6 to 3.0
|
—
|
—
|
—
|
—
|
—
|
17.5 months
Interval 17.5 to 17.5
|
4.1 months
Interval 2.8 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 281 weeksPopulation: Participants in the All Enrolled Analysis Set with CLL were analyzed.
Achieving Minimal Residual Disease was defined as \< 1 leukemia cell/10,000 leukocytes (10-4) in participants who have also achieved a CR. CR is defined in outcome measure #2.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=1 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=1 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=6 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=1 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=7 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
n=29 Participants
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Minimal Residual Negative Disease (< 1 Leukemia Cell/10,000 Leukocytes) During the Dose Escalation Phase and Dose Expansion Phase in Participants With CLL
|
0 percentage of participants
|
40 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
—
|
0 percentage of participants
|
—
|
0 percentage of participants
|
—
|
—
|
28.6 percentage of participants
|
—
|
—
|
—
|
20.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8: Predose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Participants in the tirabrutinib PK Analysis Set with available data were analyzed. The PK Analysis Set included participants who received at least 1 dose of study drug and had at least 1 non-missing post-dose concentration value reported by the PK laboratory.
AUCtau was defined as concentration of drug over time. Area under the concentration verses time curve over the dosing interval (AUctau). The data for AUCtau is reported for tirabrutinib 80 mg as monotherapy and in combination with idelalisib 50 mg and 100 mg and entospletinib 200 mg and 400 mg.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=9 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: AUCtau of Tirabrutinib 80 mg
|
984.0 ng*h/mL
Standard Deviation 342.18
|
1205.6 ng*h/mL
Standard Deviation 245.89
|
1794.1 ng*h/mL
Standard Deviation 181.15
|
1251.6 ng*h/mL
Standard Deviation 387.46
|
1088.8 ng*h/mL
Standard Deviation 545.52
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8: Predose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: The participants in the tirabrutinib PK analysis set with available data were analyzed.
Cmax was defined as the maximum observed concentration of drug. The data for Cmax is reported for tirabrutinib 80 mg as monotherapy and in combination with idelalisib 50 mg and 100 mg and entospletinib 200 mg and 400 mg.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=10 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of Tirabrutinib 80 mg
|
192.3 ng/mL
Standard Deviation 58.21
|
219.5 ng/mL
Standard Deviation 12.02
|
304.7 ng/mL
Standard Deviation 34.67
|
246.3 ng/mL
Standard Deviation 11.37
|
215.2 ng/mL
Standard Deviation 66.10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8: Predose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Participants in the Idelalisib PK analysis set with available data were analyzed.
AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=2 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=4 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: AUCtau of Idelalisib When Given in Combination With Tirabrutinib
|
6620.6 h*ng/mL
Standard Deviation 661.19
|
5433.2 h*ng/mL
Standard Deviation 1287.95
|
6735.0 h*ng/mL
Standard Deviation 1859.79
|
9488.0 h*ng/mL
Standard Deviation 3263.44
|
19305.4 h*ng/mL
Standard Deviation 5616.53
|
7093.0 h*ng/mL
Standard Deviation 4025.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8: Predose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Participants in the Idelalisib PK analysis set with available data were analyzed.
Cmax was defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=2 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=4 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of Idelalisib When Given in Combination With Tirabrutinib
|
1920.0 ng/mL
Standard Deviation 252.39
|
1893.3 ng/mL
Standard Deviation 750.82
|
1324.8 ng/mL
Standard Deviation 389.65
|
1790.0 ng/mL
Standard Deviation 268.70
|
3325.0 ng/mL
Standard Deviation 481.28
|
1844.0 ng/mL
Standard Deviation 518.58
|
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Cycle 1 Day 8: Predose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Participants in the Idelalisib Metabolite PK Analysis Set with available data were analyzed. The Idelalisib Metabolite PK Analysis Set included participants who received at least 1 dose of study drug and had at least 1 nonmissing post-dose concentration value reported by the PK laboratory.
AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=2 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: AUCtau of Metabolite of Idelalisib (GS-563117) When Given in Combination With Tirabrutinib
|
19922.6 h*ng/mL
Standard Deviation 9354.47
|
22519.6 h*ng/mL
Standard Deviation 8233.77
|
41327.5 h*ng/mL
Standard Deviation 20049.44
|
49192.7 h*ng/mL
Standard Deviation 15719.52
|
36824.3 h*ng/mL
Standard Deviation 9670.67
|
225371.5 h*ng/mL
Standard Deviation 22931.89
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8: Predose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Participants in the Idelalisib Metabolite PK Analysis Set with available data were analyzed.
Cmax was defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=2 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=4 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of Metabolite of Idelalisib (GS-563117) When Given in Combination With Tirabrutinib
|
2723.3 ng/mL
Standard Deviation 1045.10
|
2760.0 ng/mL
Standard Deviation 1105.31
|
2542.5 ng/mL
Standard Deviation 1820.54
|
3415.0 ng/mL
Standard Deviation 360.62
|
2592.5 ng/mL
Standard Deviation 503.48
|
3682.0 ng/mL
Standard Deviation 1950.35
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8: Predose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Participants in the Entospletinib PK Analysis Set with available data were analyzed.
AUCtau was defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=2 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: AUCtau of Entospletinib When Given in Combination With Tirabrutinib
|
7738.7 h*ng/mL
Standard Deviation 1793.68
|
4266.2 h*ng/mL
Standard Deviation 1574.30
|
9968.3 h*ng/mL
Standard Deviation 295.69
|
14027.8 h*ng/mL
Standard Deviation 6979.18
|
12959.9 h*ng/mL
Standard Deviation 2250.66
|
6196.8 h*ng/mL
Standard Deviation 1018.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8: Predose and 0.5, 1, 2, 3, 4, 6, 8 and 24 hours postdosePopulation: Participants in the Entospletinib PK Analysis Set with available data were analyzed.
Cmax was defined as the maximum observed concentration of drug.
Outcome measures
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=3 Participants
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=4 Participants
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks.
|
Group VI Single Agent Tirabrutinib: CLL
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter: Cmax of Entospletinib When Given in Combination With Tirabrutinib
|
876.0 ng/mL
Standard Deviation 367.98
|
707.7 ng/mL
Standard Deviation 397.04
|
697.0 ng/mL
Standard Deviation 313.93
|
1498.7 ng/mL
Standard Deviation 619.57
|
1330.7 ng/mL
Standard Deviation 382.0
|
861.0 ng/mL
Standard Deviation 276.17
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 2 deaths
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
Serious events: 13 serious events
Other events: 24 other events
Deaths: 6 deaths
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
Serious events: 36 serious events
Other events: 73 other events
Deaths: 8 deaths
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
Serious events: 7 serious events
Other events: 7 other events
Deaths: 1 deaths
Group V Single Agent Tirabrutinib 80 mg
Serious events: 10 serious events
Other events: 29 other events
Deaths: 3 deaths
Group VI Single Agent Tirabrutinib: CLL
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group VI Single Agent Tirabrutinib: NHL
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 participants at risk
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=8 participants at risk
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=25 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=9 participants at risk
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 participants at risk
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=3 participants at risk
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=6 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 participants at risk
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=3 participants at risk
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=78 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=8 participants at risk
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=6 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=7 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
n=29 participants at risk
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks
|
Group VI Single Agent Tirabrutinib: CLL
n=3 participants at risk
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
n=3 participants at risk
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Death, not otherwise specified
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Immune system disorders
Cytokine storm
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Covid-19
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Diverticulitis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Empyema
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Ovarian abscess
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biphasic mesothelioma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma metastatic
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Vasculitic ulcer
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
Other adverse events
| Measure |
Combination I (Tirabrutinib 20 mg QD+ Idelalisib 50 mg BID)
n=3 participants at risk
Participants received tirabrutinib 20 mg tablet once daily (QD) for up to 209 weeks and idelalisib 50 mg tablet twice daily (BID) orally for up to 120 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 40 mg QD+ Idelalisib 50 mg BID)
n=8 participants at risk
Participants received tirabrutinib 40 mg tablet QD for up to 251 weeks and idelalisib 50 mg tablet BID orally, for up to 245 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 50 mg BID)
n=4 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 212 weeks and idelalisib 50 mg tablet BID orally, for up to 26 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD)
n=25 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 227 weeks and idelalisib 100 mg tablet QD orally, for up to 227 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 160 mg QD+ Idelalisib 100 mg QD)
n=9 participants at risk
Participants received tirabrutinib 160 mg tablet QD for up to 151 weeks and idelalisib 100 mg tablet QD orally, for up to 151 weeks. Both drugs were administered for 28-day cycles.
|
Combination I (Tirabrutinib 20 mg BID+ Idelalisib 50 mg BID)
n=5 participants at risk
Participants received tirabrutinib 20 mg tablet BID for up to 207 weeks and idelalisib 50 mg tablet BID orally, for up to 207 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 200 mg QD)
n=3 participants at risk
Participants received tirabrutinib 40 mg tablet QD for up to 250 weeks and entospletinib 200 mg tablet QD orally, for up to 250 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 200 mg QD)
n=6 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 234 weeks and entospletinib 200 mg tablet QD orally, for up to 220 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 150 mg QD+ Entospletinib 200 mg QD)
n=3 participants at risk
Participants received tirabrutinib 150 mg tablet QD for up to 103 weeks and entospletinib 200 mg tablet QD orally, for up to 88 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 40 mg QD+ Entospletinib 400 mg QD)
n=3 participants at risk
Participants received tirabrutinib 40 mg tablet QD for up to 119 weeks and entospletinib 400 mg tablet QD orally, for up to 119 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD)
n=78 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 232 weeks and entospletinib 400 mg tablet QD orally, for up to 229 weeks. Both drugs were administered for 28-day cycles.
|
Combination II (Tirabrutinib 160 mg QD+ Entospletinib 400 mg QD)
n=8 participants at risk
Participants received tirabrutinib 160 mg tablet QD for up to 44 weeks and entospletinib 400 mg tablet QD orally, for up to 44 weeks. Both drugs were administered for 28-day cycles.
|
Combination III (Tirabrutinib 80 mg QD+ Idelalisib 100 mg QD+ Obinutuzumab 1000 mg)
n=6 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 199 weeks; Idelalisib 100 mg tablet QD orally for up to 199 weeks, and single dose of obinutuzumab 1000 mg intravenously (IV) for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Combination IV(Tirabrutinib 80 mg QD+ Entospletinib 400 mg QD+Obinutuzumab 1000 mg)
n=7 participants at risk
Participants received tirabrutinib 80 mg tablet QD for up to 196 weeks; entospletinib 400 mg tablet QD orally for up to 196 weeks and single dose of obinutuzumab 1000 mg IV for up to 22 weeks. All drugs were administered for 28-day cycles.
|
Group V Single Agent Tirabrutinib 80 mg
n=29 participants at risk
Participants received tirabrutinib 80 mg tablet QD orally, for each 28-day cycle up to 194 weeks
|
Group VI Single Agent Tirabrutinib: CLL
n=3 participants at risk
Participants with CLL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 40 - 400 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
Group VI Single Agent Tirabrutinib: NHL
n=3 participants at risk
Participants with NHL who received tirabrutinib in this or previous tirabrutinib study, continued to receive tirabrutinib at the original dose (between the range of 60 - 480 mg), tablet QD, for each 28-day cycle up to 441 weeks. Participants were monitored for long-term safety of tirabrutinib this group.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
8/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.6%
2/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.2%
5/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
37.5%
3/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
2/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
32.0%
8/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
3/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.9%
14/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
57.1%
4/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
13.8%
4/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
2/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.0%
4/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
3/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
8/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
42.9%
3/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Blood and lymphatic system disorders
Warm autoimmune haemolytic anaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
5.1%
4/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Congenital, familial and genetic disorders
Porokeratosis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Conjunctival haemorrhage
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Macular hole
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Ocular hyperaemia
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Scleritis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.5%
9/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.6%
2/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Apical granuloma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
80.0%
4/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.1%
11/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
42.9%
3/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
27.6%
8/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
62.5%
5/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
5/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
44.4%
4/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
3/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
30.8%
24/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
37.5%
3/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
3/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.6%
2/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
34.5%
10/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
4/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
22.2%
2/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.5%
9/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
13.8%
4/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.4%
5/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
23.1%
18/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
34.5%
10/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Oral blood blister
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.1%
11/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
21.8%
17/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
42.9%
3/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Chest pain
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Cyst
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
66.7%
4/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
26.9%
21/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
27.6%
8/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Hyperthermia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Injection site haematoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Localised oedema
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.7%
6/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Pain
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
5.1%
4/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Peripheral swelling
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
General disorders
Pyrexia
|
100.0%
3/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.9%
14/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Abscess
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Bartholinitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Bronchitis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.0%
4/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
7.7%
6/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.6%
2/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.2%
5/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.4%
5/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Cholangitis infective
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Conjunctivitis
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Covid-19
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.4%
5/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.7%
6/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
5.1%
4/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Soft tissue infection
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Gastroenteritis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Infected bite
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
9.0%
7/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Lower respiratory tract infection
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
7.7%
6/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.2%
5/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Lymph gland infection
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.0%
4/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
13/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
42.9%
3/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
13.8%
4/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Oral infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Pharyngitis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.4%
5/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.2%
5/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
2/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
5/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.5%
9/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.6%
2/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.2%
5/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Tongue fungal infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Toxocariasis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
4/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
7.7%
6/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
24.1%
7/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Urinary tract infection
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.4%
5/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Contusion
|
100.0%
3/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.0%
4/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
19.2%
15/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.7%
6/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Eye abrasion
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
2/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
8/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
66.7%
4/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.6%
2/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Oral contusion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
3/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
9.0%
7/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
22.2%
2/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
7.7%
6/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Blood urine present
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Fungal test positive
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Sars-cov-2 test positive
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
13.8%
4/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
60.0%
3/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.5%
9/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
24.0%
6/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
13/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.7%
6/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.4%
5/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.0%
4/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
3/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.9%
14/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.7%
6/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
9.0%
7/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
13.8%
4/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
5.1%
4/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Akathisia
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.0%
4/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.5%
9/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.6%
2/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
24.1%
7/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
5.1%
4/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
22.2%
2/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.5%
9/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
13.8%
4/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
5.1%
4/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
3/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Micturition urgency
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Urinary incontinence
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Reproductive system and breast disorders
Breast induration
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
4/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.0%
4/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
22.2%
2/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
3/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.9%
14/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
66.7%
4/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.6%
2/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
24.1%
7/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.0%
4/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
40.0%
2/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
15.4%
12/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
13.8%
4/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
9.0%
7/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.8%
3/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.4%
5/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.7%
6/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
50.0%
2/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
15.4%
12/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
13.8%
4/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.1%
11/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
5.1%
4/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
2/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.0%
7/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.1%
11/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
17.2%
5/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
22.2%
2/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
8.0%
2/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
3.4%
1/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
1.3%
1/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
25.0%
1/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
7.7%
6/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
2/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
14.3%
1/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
20.0%
1/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
4.0%
1/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
11.1%
1/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.5%
1/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
7.7%
6/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
28.6%
2/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
10.3%
3/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
2.6%
2/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.9%
2/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
12.0%
3/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
6.4%
5/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
13.8%
4/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
33.3%
1/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/4 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/25 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/9 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/5 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/78 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/8 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
16.7%
1/6 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/7 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/29 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
0.00%
0/3 • Up to 441 weeks plus 30 days
All-Cause mortality: All Enrolled Analysis Set includes all participants who received a participant ID number in the study after screening. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER